Health Trials

VIrtual Care To Improve Outcomes and RecoverY From Heart Failure Hospitalization

ConditionHeart Failure
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorPopulation Health Research Institute

About this trial

The clinic visits (intervention) will continue for 90 days, which represents the follow-up period for the primary medication and health status outcomes. The co-primary clinical outcomes will be obtained at 180 days.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Are being discharged after hospitalization or urgent visit for HF as

a primary diagnosis or

significant complication (prolonging length of stay) of another diagnosis OR Have been referred for an initial consult at a cardiology clinic within 1 week of hospitalization or urgent visit for HF as a primary or secondary diagnosis, as described above.

Have left ventricular ejection fraction (LVEF) < 50% within the preceding 3 months.

Disqualifiers

Died or left hospital before medically advised hospital discharge

Unable to self-assess or communicate symptoms (e.g. clinically evident dementia)

Unable to engage with digital health technology or follow up

Severe valve disease

Trial design

Design model

Parallel

Treatments tested in this trial

  • Virtual HF Care

    Other intervention

    Patients will receive virtual visits for 3 months following hospitalization / emergency department (ED) visit for HF. Physiologic measures will be monitored remotely and therapies will be optimized.

  • Routine HF Care

    Other intervention

    Care as determined by the treating physician

Treatment groups

891 Participants
are divided into 2 treatment groups
Group A: Virtual HF careExperimental treatment 1 intervention
Group B: Routine HF careOther 1 intervention

Trial outcomes

Primary outcomes

1

Primary "Hierarchical" Composite Outcome of (Part 1):

Target dose of beta blockers (BB), angiotensin receptor-neprilysin inhibitor (ARNI) or angiotensin-converting enzyme inhibitor (ACEi) / angiotensin receptor blocker (ARB), mineralocorticoid receptor antagonist (MRA), and sodium-glucose cotransporter-2 inhibitor (SGLT2i) at 90 days.

Time frame
30 and 90 days
2

Primary "Hierarchical" Composite Outcome of (Part 2):

2\. Guideline-directed medical therapy (GDMT) intensification at 30 days, defined as: 1. initiation or up-titration of a beta blocker; 2. switch from another beta blocker to carvedilol, bisoprolol, or extended-release metoprolol succinate; 3. initiation or up-titration of an angiotensin-converting enzyme inhibitor (ACE inhibitor), angiotensin receptor blocker (ARB), or angiotensin receptor-neprilysin inhibitor (ARNI); 4. switch from an angiotensin-converting enzyme inhibitor (ACE inhibitor) or angiotensin receptor blocker (ARB) to an angiotensin receptor-neprilysin inhibitor (ARNI); 5. initiation or up-titration of a mineralocorticoid receptor antagonist (MRA); or 6. initiation of a sodium-glucose cotransporter-2 inhibitor (SGLT2 inhibitor).

Time frame
Time Frame: 30 and 90 Days
3

Primary "Hierarchical" Composite Outcome of (Part 3):

Change in health status, as measured by the Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days.

Time frame
Time Frame: 30 and 90 days.
4

Co-primary "Hierarchical" Composite Outcome of:

1. All-cause death at 180 days. 2. Heart failure (HF) hospitalization at 180 days. 3. All-cause emergency department (ED) visit at 180 days. 4. Change in Kansas City Cardiomyopathy Questionnaire-12 (KCCQ-12) summary score at 90 days. These Co-Primary Hierarchical Composite Outcomes were the original Primary Outcomes for this trial. The Primary "Original" Outcome listed below applies only to the single-center pilot phase of the trial.

Time frame
90 and 180 days

Secondary outcomes

1

Guideline-Directed Medical Therapy (GDMT) use

Achievement of at least 50% of the target doses of beta blockers, angiotensin-converting enzyme inhibitors/angiotensin receptor blockers or angiotensin receptor-neprilysin inhibitors, mineralocorticoid receptor antagonists, sodium-glucose cotransporter-2 inhibitors at 90 days.

Time frame
90 days
2

Clinical Outcomes

i) Time to composite all-cause death, heart failure hospitalization, or all-cause emergency department visit at 180 days ii) Components of composite endpoint * Time to all-cause death * Time to heart failure hospitalization * Time to all-cause emergency department visit iii) Change in health status (Kansas City Cardiomyopathy Questionnaire-12 summary score) at 90 days The Secondary "Original" Outcomes listed below apply only to the single-center pilot phase.

Time frame
90 days and 180 days
3

Healthcare utilization

i) direct healthcare cost at 90 and 180 days. ii) number of virtual and in-person clinic visits per patient in 90 days.

Time frame
90 days and 180 days

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Population Health Research Institute

Lead sponsor

Hamilton Health Sciences Corporation

Collaborator

McMaster University

Collaborator

Source ClinicalTrials.gov
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